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NCT Number: NCT06938451

Relationship Between FGF19 Overexpression and Disease Prognosis

A real-world study of FGF19 overexpression status and treatment outcome and prognosis in advanced hepatocellular carcinoma

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location contact

LI GONG LIGONG, phD

SUB_INVESTIGATOR

LI GUANGXIN LIGUANGXIN, phD

SUB_INVESTIGATOR

ZHAO YING ZHAOYING, phD

CONTACT

[email protected]

86+13810943515

ZHAO YING ZHAOYING, phD

PRINCIPAL_INVESTIGATOR

About this study

This is a real-world, single-arm, observational study to collect information on the diagnosis and prognosis of hepatocellular carcinoma patients with previous tissue samples in routine clinical practice, and to detect the expression of FGF19 expression in tissue samples, with a view to discovering prognostic and predictive markers for advanced hepatocellular carcinoma The treatment protocol of this study follows the clinical practice and does not set any limitations on the interventions for patients.

In this study, real-world liver tissue samples will be collected from patients with hepatocellular liver cancer after surgical resection, and the samples will be sent to a third-party pathology slice reviewer for review, and a report on the FGF19 expression results will be returned to the project team. Simultaneously collect clinical data of the patient.

According to the principle of clinical routine diagnosis and treatment, the patient's imaging data were collected, and the imaging of the 2-month period was evaluated, and whether the disease progressed was judged according to the RESCIST v1.1 standard. Every two months will be an observation cycle. Each subject will be followed from the first treatment until disease progression or change of drug regimen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years on the day of signing the informed consent form
  • Histologically or clinically confirmed diagnosis of intermediate to advanced HCC
  • Adequate tissue samples of previous liver cancer
  • Expected survival of more than 3 months

Exclusion criteria

  • Fibrous laminae or sarcomatoid HCC or mixed HCC-ICC, or other rare non-HCC pathologic subtypes
  • Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: Enrollment until disease progression

    PFS was calculated from the date of randomization to the date of the first documented disease progression, with no time constraints involved, marked by the appearance of disease progression

  2. OS

    Time frame: Start of enrollment until death (from any cause)

    Observation until death from the beginning of participation in the study observation until death from any cause, no time frame limitations were involved. Calculation of OS based on time of death

Secondary outcomes

  1. ORR

    Time frame: Time to enrollment until disease downsizing

    Proportion of patients whose tumor volume shrinks to a preset value and remains unchanged for a given period of time, total study duration 36 months, ORR observation period within 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

ZHAOYING Resident physician, phD

CONTACT

[email protected]

86+13810943515

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

A Real-world Study of FGF19 Overexpression Status and Treatment Outcome and Prognosis in Advanced Hepatocellular Carcinoma

Acronym: FGF19

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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